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Completed

NCT Number: NCT05981924

Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

To explore the feasibility and effectiveness of Perioperative Music Therapy Plus Oxycodone in pain management after thoracic surgery, patients will be randomly assigned into two groups. The experimental group will receive perioperative music therapy and the control group will not. We will record and contrast the postoperative oxycodone usage to evaluate the effect of music therapy in relieving the pain. We will also use visual analogue scale, questionnaire and EEG to evaluate patients' anxiety and depression.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enhanced CT or PET/CT indicate primary malignant pulmonary nodule;
  • The clinical stage belongs to cT1-4N0-2M0 before treatment or ycT1-4N0-2M0 after neoadjuvant treatment (AJCC/TNM 8th Edition);
  • Suitable for video-assisted thoracoscopic surgery after evaluated by thoracic surgeon;
  • FEV1 > 1.5L and DLCO > 60% pred;
  • Hearing loss lesser than 35 decibels (dB) in the better hearing ear;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
  • American Society of Anesthesiologists Score of 1 or 2;
  • Confirmed eligibility for R0 resection for curative intent by thoracic surgeon assessment;
  • Adequate cardiopulmonary function, confirmed to meet the requirement for surgical resection for curative intent;
  • Able to provide written informed consent and able to understand and agree to comply with study requirements and evaluation forms;
  • Life expectancy greater than 12 months

Exclusion criteria

  • Enhanced CT or PET/CT indicate metastatic malignant pulmonary nodule;
  • Hearing loss greater than 35 decibels (dB) in the better hearing ear;
  • Active autoimmune disease or history of autoimmune disease that may recur; Note: well-controlled type 1 diabetes is allowed; hypothyroidism (controlled with thyroid hormone replacement only); well-controlled celiac disease; skin disease not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia); any other condition that is not expected to recur in the absence of an external trigger.
  • History of interstitial lung disease, pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease;
  • Serious infection occurred before grouping, including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; severe chronic or active infection (including pulmonary tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibiotics within 14 days before grouping;
  • Simultaneous participation in another therapeutic clinical study;
  • Pregnant or lactating women, or male and female patients planning to have children during the study;
  • Other conditions that the investigators consider inappropriate for participation in this trial, such as poor compliance.

Treatment and study plan

Perioperative Music Therapy

Other

Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia

Primary outcomes

  1. The total dose of oxycodone within 48 hours after surgery

    Time frame: 48 hours after surgery

    The total dose of oxycodone within 48 hours after surgery

Secondary outcomes

  1. The VSA-A Score

    Time frame: From 1 day before surgery to the third day after surgery

    The Visual Analogue Scale-Anxiety Score at different observation point

  2. The VSA-P Score

    Time frame: From the first day to the third day after surgery

    The Visual Analogue Scale-Pain Score at different observation point

  3. The incidence rate of analgesic related adverse reaction

    Time frame: 48 hours after surgery

    The incidence rate of analgesic related adverse reaction within 72 hours after surgery

  4. The usage of extra analgesics after surgery

    Time frame: 48 hours after surgery

    The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine

  5. The kind and usage of anesthetics for anesthesia induction and maintenance

    Time frame: During the surgery

    The kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium

  6. The quality of life after treatment

    Time frame: The third day after surgery

    The quality of life assessed by questionnaire on the third day after surgery

  7. The press times of PCIA pump within 48 hours after surgery

    Time frame: 48 hours after surgery

    The press times of PCIA pump within 48 hours after surgery

Other outcomes

  1. Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment

    Time frame: 1 hour before surgery

    Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment

  2. Changes of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment

    Time frame: 1 hour before surgery

    Changes of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment

Sponsors and collaborators

Lead sponsor

Hao Long

Other

Collaborators

  • Sun Yat-sen University Department of Psychology
  • Sun Yat-sen University School of Art

Registry information

Official study title

Effects of Music Therapy on Perioperative Anxiety and Pain Management in Lung Surgery: A Randomized, Prospective, Multidisciplinary Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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